Systems and methods for decorticating the sacroiliac joint

ABSTRACT

A system for decorticating at least one bone surface includes an elongated soft tissue protector, an elongated drive shaft and a cutter. The elongated soft tissue protector has a bore extending therethrough. The bore has a non-circular lateral cross-section, a maximum lateral extent and a minimum lateral extent. The cutter may be located on or near a distal end of the drive shaft. The cutter has a non-circular lateral cross-section, a maximum lateral extent and a minimum lateral extent. The maximum lateral extent of the cutter is greater than the minimum lateral extent of the bore but is no greater than the maximum lateral extent of the bore. The bore of the soft tissue protector is configured to slidably receive the cutter therethrough. Other systems and methods for decorticating at least one bone surface are also provided.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/563,271, filed Sep. 26, 2017.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference for all intents and purposes to thesame extent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

Embodiments of the disclosure relate generally to fixation or fusion ofa bone joint, and more specifically, to decorticating a joint inpreparation for joint fixation or fusion.

BACKGROUND

Sacroiliac joint (SI-Joint) fusion is a surgical procedure that isperformed to alleviate pain coming from the SI-Joint in patients whohave failed to receive adequate pain relief with non-surgical treatmentsof the SI-Joint. Some conditions of the SI-Joint that may be treatedwith SI-Joint fusion (arthrodesis) are: degenerative sacroiliitis,inflammatory sacroiliitis, iatrogenic instability of the sacroiliacjoint, osteitis condensans ilii, or traumatic fracture dislocation ofthe pelvis. Historically, screws and screws with plates were used as thestandard instrumentation for sacro-iliac fusion. An SI-Joint fusionconsisted of an open surgical approach to the SI-Joint from an anterior,a posterior, or a lateral direction. The surgeon would then debride(remove) the cartilage from the articular portion of the joint and theinterosseous ligament from the fibrous portion of the joint. These openapproaches require a large incision and deep soft tissue dissection toapproach the damaged, subluxed, dislocated, fractured, or degenerativeSI-Joint.

With more recent advancements in SI-Joint surgery, a typical techniquefor placing implants involves placement of one or multiple implants froma lateral to medial direction across the SI-Joint. These implants areplaced with a starting point on the lateral aspect of the ilium. Theimplants are then directed across the ilium, across the sacroiliac jointand into the sacrum.

No debridement or decortication of the articular surfaces of theSI-Joint is done in many SI-Joint fusion procedures performed today.However, some surgeons believe that decortication of the joint wouldpromote faster and stronger fusion of the joint.

Accordingly, it would be desirable to provide systems and methods fordecorticating portions of the SI-Joint in a minimally invasive fashionduring SI-Joint fusion surgery.

SUMMARY

According to aspects of the disclosure, systems and methods fordecorticating at least one bone surface are provided. In someembodiments, the systems include an elongated soft tissue protector, anelongated drive shaft and a cutter. The elongated soft tissue protectorhas a bore extending therethrough. The bore has a non-circular lateralcross-section, a maximum lateral extent and a minimum lateral extent.The elongated drive shaft has a proximal and a distal end. The cuttermay be located on or near the distal end of the drive shaft. The cutterhas a non-circular lateral cross-section, a maximum lateral extent and aminimum lateral extent. The maximum lateral extent of the cutter isgreater than the minimum lateral extent of the bore but is no greaterthan the maximum lateral extent of the bore. The bore of the soft tissueprotector is configured to slidably receive the cutter therethrough. Theminimum lateral extent of the bore prevents the maximum lateral extentof the cutter from rotating when inside the bore but allows the driveshaft to rotate when the cutter is extended from a distal end of thebore.

In some embodiments, the bore of the soft tissue protector has arectilinear lateral cross-sectional profile. The rectilinear lateralcross-sectional profile may be generally triangular in shape. The systemmay further include a body that is provided with a cylindrical boretherethrough, wherein the cylindrical bore is configured to slidably androtatably receive the drive shaft. The body may be configured to beslidably received within the bore of soft tissue protector. In someembodiments, the drive shaft and cutter are provided with a longitudinalbore sized to slide over a guide pin.

In some embodiments, the proximal end of the drive shaft is providedwith a handle configured to allow the drive shaft to be manually rotatedand moved longitudinally relative to the soft tissue protector. Theproximal end of the drive shaft may be provided with an indexing featureconfigured to show a rotational orientation of the drive shaft and thecutter relative to the soft tissue protector so that the cutter can bealigned with and retracted into the soft tissue protector. In someembodiments, the system includes a navigation array mounted near theproximal end of the drive shaft. The array includes a plurality ofemitters or reflectors located at predetermined and unique distancesfrom one another to generate a signal to aid in navigation of the cutterwith regard to a reference frame associated with a patient on an imagingsystem.

In some embodiments, a method of decorticating at least one bone surfaceincludes the steps of forming an implant bore across a first bone into aspace between the first bone and an adjacent second bone, inserting acutter of a decorticating device through the implant bore, and rotatingthe cutter. In this embodiment, the implant bore has a non-circularlateral cross-section, a maximum lateral extent and a minimum lateralextent. The cutter has a non-circular lateral cross-section, a maximumlateral extent and a minimum lateral extent. The maximum lateral extentof the cutter is greater than the minimum lateral extent of the implantbore but no greater than the maximum lateral extent of the implant bore.In the cutter rotating step, the maximum lateral extent of the cutterextends laterally beyond the implant bore and decorticates a surface ofat least one of the first and second bones.

In some embodiments of the above methods, the first bone is an ilium andthe second bone is a sacrum. The method may further include withdrawingthe cutter from the implant bore and placing an implant into the implantbore. In some embodiments, the implant bore has a rectilinear lateralcross-sectional profile. The rectilinear lateral cross-sectional profilemay be generally triangular in shape. In some embodiments, the methodfurther includes inserting a guide pin across the first bone and intothe second bone, and sliding the cutter of the decortication device overthe guide pin.

In some embodiments, the decorticating device further comprises a handleand a drive shaft interconnecting the handle to the cutter. The methodmay further include manually manipulating the handle to rotate thecutter and to move the cutter longitudinally relative to the implantbore. The handle or a proximal end of the drive shaft may be providedwith an indexing feature configured to show a rotational orientation ofthe drive shaft and the cutter relative to the implant bore. In someembodiments, the method further includes manipulating the handle toalign the cutter with and retract the cutter through the non-circularimplant bore.

In some embodiments, systems for decorticating at least one bone surfaceinclude an elongated drive shaft, an elongated body and anon-symmetrical offset cutter. The elongated body has a centrallongitudinal axis and a bore extending therethrough. The bore isparallel to and laterally offset from the central longitudinal axis andis configured to slidably and rotatably receive the drive shafttherethrough. The non-symmetrical offset cutter is located on or near adistal end of the drive shaft. The cutter has a profile that fits withina lateral cross-section of the elongated body in at least oneorientation and extends laterally outside of the cross-section when thedrive shaft and cutter are rotated.

In some embodiments of the above systems, the lateral cross-section ofthe elongated body has a rectilinear profile. The rectilinear profilemay be generally triangular in shape. In some embodiments, the systemfurther includes a navigation array mounted near a proximal end of thedrive shaft. The array includes a plurality of emitters or reflectorslocated at predetermined and unique distances from one another togenerate a signal to aid in navigation of the cutter with regard to areference frame associated with a patient on an imaging system.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the features and advantages of the presentdisclosure will be obtained by reference to the following detaileddescription that sets forth illustrative embodiments, in which theprinciples of the disclosure are utilized, and the accompanying drawingsof which:

FIGS. 1 and 2 are, respectively, anterior and posterior anatomic viewsof the human hip girdle comprising the sacrum and the hip bones (theright ilium, and the left ilium), the sacrum being connected with bothhip bones at the sacroiliac joint (in shorthand, the SI-Joint).

FIGS. 3 and 4 are embodiments of various implants that can be used forthe fusion or fixation of a joint or two bone segments.

FIG. 5 illustrates an axial section view of the SI-Joint with an implantfor the fixation of the SI-Joint using a lateral approach that goeslaterally through the ilium, the SI-Joint, and into the sacrum S1.

FIG. 6 illustrates an axial section view of the SI-Joint with an implantfor the fixation of the SI-Joint using a postero-lateral approachentering from the posterior iliac spine of the ilium, angling throughthe SI-Joint, and terminating in the sacral alae.

FIGS. 7A-7D are side section views of the formation of a broached borein bone according to one embodiment of the disclosure.

FIGS. 7E and 7F illustrate the assembly of a soft tissue protectorsystem for placement over a guide wire.

FIGS. 8 to 10 are anatomic views showing, respectively, a pre-implantedperspective, implanted perspective, and implanted anterior view, theimplantation of three implant structures for the fixation of theSI-Joint using a lateral approach through the ilium, the SI-Joint, andinto the sacrum.

FIG. 11A is a perspective view showing an exemplary embodiment of adecorticating system constructed according to aspects of the presentdisclosure.

FIG. 11B is an enlarged perspective view showing the cutter of thesystem of FIG. 11A.

FIG. 12 is an end view depicting an exemplary decortication areaprovided by the system of FIG. 11A.

FIG. 13A is a perspective view showing another exemplary cutter that maybe used with the system of FIG. 11A.

FIG. 13B is a perspective view showing another exemplary cutter that maybe used with the system of FIG. 11A.

FIG. 14 is a perspective view showing another exemplary embodiment of adecorticating system.

FIG. 15 is an enlarged perspective view showing the distal end of thesystem of FIG. 14.

FIG. 16 is a perspective view showing another exemplary embodiment of adecorticating system.

FIG. 17 is an exploded view showing the components of the system of FIG.16.

FIG. 18 is an enlarged end view showing the distal end of the system ofFIG. 16.

FIG. 19 is an enlarged perspective view showing the concave side andradially outward side of the cutter of FIG. 16.

FIG. 20 is an enlarged side view showing the concave side of the cutterof FIG. 16.

FIG. 21 is an enlarged perspective view showing the convex side andradially outward side of the cutter of FIG. 16.

FIG. 22 is an enlarged end view showing the radially outward side of thecutter of FIG. 16.

FIG. 23 is an end view depicting an exemplary decortication areaprovided by the system of FIG. 16 when used in a single apex of atriangular soft tissue protector.

FIG. 24 is an end view depicting an exemplary decortication areaprovided by the system of FIG. 16 when used in all three apexes of atriangular soft tissue protector.

FIG. 25 is a perspective view showing an impactor tool configured foruse with the system of FIG. 16.

FIG. 26 is a perspective view showing a removal tool configured for usewith the system of FIG. 16.

FIG. 27 is a perspective view showing another exemplary embodiment of adecorticating system.

FIG. 28 is an exploded view showing the components of the system of FIG.27.

FIG. 29 is a perspective view showing another exemplary embodiment of adecorticating system.

FIG. 30 is a perspective view showing another exemplary embodiment of adecorticating system.

FIG. 31 is an enlarged perspective view showing the distal end of thesystem of FIG. 30.

FIG. 32 is a perspective view showing a longitudinal cross-section ofanother exemplary embodiment of a decorticating system in a retractedstate.

FIG. 33 is a side view showing a longitudinal cross-section of thesystem of FIG. 32 in a retracted state.

FIG. 34 is a perspective view showing another exemplary embodiment of adecorticating system, with the outer components shown in a transparentfashion so that inner features may be seen.

FIG. 35 is an exploded view showing the components of the system of FIG.34, with the outer components shown in a transparent fashion so thatinner features may be seen.

FIG. 36 is a perspective view showing another exemplary embodiment of adecorticating system, with the outer components shown in a transparentfashion so that inner features may be seen.

FIG. 37 is an exploded view showing the components of the system of FIG.36, with the outer components shown in a transparent fashion so thatinner features may be seen.

FIG. 38 is a side view showing the right side of a sacrum with the iliumremoved for clarity, with an extra channel formed across the SI-Jointaccording to aspects of the disclosure to aid in decorticating the bonejoint.

FIG. 39 is a perspective view showing an exemplary embodiment of adecorticating decortication system having navigational features.

FIG. 40 is a perspective view showing another exemplary embodiment of adecorticating system in a closed state.

FIG. 41 is a perspective view showing the decorticating system of FIG.40 in an open state.

FIG. 42 is an exploded view showing the components of the decorticatingsystem of FIG. 40.

FIG. 43 is a pair of distal tip end views showing another exemplaryembodiment of a decorticating system in both a closed state (upperinset) and an open state (lower inset.)

FIG. 44 is an exploded view showing the components of another exemplaryembodiment of a decorticating system

DETAILED DESCRIPTION

A joint of a patient can be decorticated or selectively decorticated inorder to promote bone regeneration and fusion at the implant site. Manytypes of hardware are available both for the fixation of bones that arefractured and for the fixation of bones that are to be fused(arthrodesed). While the following examples focus on the SI-Joint, themethods, instrumentation and implants disclosed herein may be used fordecortication of other body joints as well.

Referring to FIGS. 1 and 2, the human hip girdle is made up of threelarge bones joined by three relatively immobile joints. One of the bonesis called the sacrum and it lies at the bottom of the lumbar spine,where it connects with the L5 vertebra. The other two bones are commonlycalled “hip bones” and are technically referred to as the right iliumand-the left ilium. The sacrum connects with both hip bones at thesacroiliac joint (in shorthand, the SI-Joint).

The SI-Joint functions in the transmission of forces from the spine tothe lower extremities, and vice-versa. The SI-Joint has been describedas a pain generator for up to 22% of lower back pain patients.

To relieve pain generated from the SI-Joint, sacroiliac joint fusion istypically indicated as surgical treatment, e.g., for degenerativesacroiliitis, inflammatory sacroiliitis, iatrogenic instability of thesacroiliac joint, osteitis condensans ilii, or traumatic fracturedislocation of the pelvis. In some currently performed procedures,screws or screws with plates are used for sacro-iliac fusion. At thetime of the procedure, articular cartilage may be removed from the“synovial joint” portion of the SI-Joint. This can require a largeincision to approach the damaged, subluxed, dislocated, fractured, ordegenerated joint. The large incision and removal of tissue can causesignificant trauma to the patient, resulting in pain and increasing thetime to heal after surgery.

In addition, screw type implants tend to be susceptible to rotation andloosening, especially in joints that are subjected to torsional forces,such as the SI-Joint. Excessive movement of the implant afterimplantation may result in the failure of the implant to incorporate andfuse with the bone, which may result in the need to remove and replacethe failed implant.

FIG. 3 and FIG. 4 illustrate straight implants 10 and 20, respectively,with a solid elongate body 12 or 12′ that can be used for the fixationor fusion of two bone segments. The implant 10 shown in FIG. 3 iscylindrical and can optionally have screw threads along the exterior ofthe implant body. As mentioned above, cylindrical screw type implantscan suffer from excessive rotation. One solution to this problem is theimplant 20 in FIG. 4, which has a non-cylindrical cross-sectional area.For example, as shown, the implant 20 can have a triangularcross-sectional area, although other rectilinear cross-sectionalprofiles may be used as well, including rectangular, hexagonal and thelike. Non-cylindrical implants need not have a strict rectilinearcross-sectional profile in order to resist rotation. A cross-sectionalarea that is non-circular will generally suffice. For example, a teardrop shaped cross-sectional area, or a cross-sectional area with atleast one apex, can resist rotation. Other non-circular cross-sectionalgeometries that may not have a rectilinear component can also work, suchas oval cross-sections.

FIG. 5 illustrates insertion of the implant 10 or 20 of FIG. 3 or FIG. 4across the SI-Joint using a lateral approach that goes laterally throughthe ilium, across the SI-Joint, and into the sacrum. FIG. 6 illustratesinsertion of the same implant across the SI-Joint using apostero-lateral approach entering from the posterior iliac spine of theilium, angling through the SI-Joint, and terminating in the sacral alae.The implants and instrumentation described herein typically can beinserted across the SI-Joint according to one of these two approaches,or with a similar approach.

Referring to FIGS. 7-10, an exemplary method for fixation of theSI-Joint will be described. Elongated, stem-like implant structures 10or 20 like those shown in FIGS. 3 and 4 make possible the fixation ofthe SI-Joint in a minimally invasive manner. These implant structurescan be effectively implanted through the use a lateral surgical approach(as shown in FIG. 5). The procedure may be aided by conventionallateral, inlet, and outlet visualization techniques, e.g., using X-rayimage intensifiers such as a C-arms or fluoroscopes to produce a liveimage feed, which is displayed on a TV screen.

In this exemplary embodiment, one or more implant structures 20 areintroduced laterally through the ilium, the SI-Joint, and into thesacrum. This path and resulting placement of the implant structure(s) 20are best shown in FIGS. 9 and 10. In the illustrated embodiment, threeimplant structures 20 are placed in this manner. Also in the illustratedembodiment, the implant structures 20 are rectilinear in cross sectionand triangular in this case, but it should be appreciated that implantstructures 20 of other rectilinear cross sections can be used.Additionally, in some procedures (not discussed in further detailherein), implants may be introduced into the SI-Joint from an anteriordirection. Further information on anterior techniques may be found inco-pending U.S. patent application Pub. No. 2015/0105828 filed Oct. 15,2014 and entitled “Implant Placement”. The decortication instruments andmethods disclosed herein and variants thereof may also be utilized inthese anterior procedures.

Before undertaking a lateral implantation procedure, the physiciandiagnoses the SI-Joint segments that are to be fixated or fused(arthrodesed) using, e.g., the Fortin finger test, thigh thrust, FABER,Gaenslen's, compression, distraction, and or diagnostic SI-Jointinjection.

Aided by lateral, inlet, and outlet C-arm views, and with the patientlying in a prone position, the physician aligns the greater sciaticnotches and then the alae (using lateral visualization) to provide atrue lateral position. A 3 cm incision is made starting aligned with theposterior cortex of the sacral canal, followed by blunt tissueseparation to the ilium. From the lateral view, the guide pin 38 (withpin sleeve (not shown)) (e.g., a Steinmann Pin) is started resting onthe ilium at a position inferior to the sacrum end plate and justanterior to the sacral canal. In the outlet view, the guide pin 38should be parallel to the sacrum end plate at a shallow angle anterior(e.g., 15 degree to 20 degree off the floor, as FIG. 10 shows). In alateral view, the guide pin 38 should be posterior to the sacrumanterior wall. In the outlet view, the guide pin 38 should be superiorto the first sacral foramen and lateral of mid-line. This correspondsgenerally to the sequence shown diagrammatically in FIGS. 7A and 7B. Asoft tissue protector (not shown), and a drill sleeve (not shown) withinthe soft tissue protector, may be slipped over the guide pin 38 andfirmly against the ilium before removing the guide pin sleeve (notshown).

Over the guide pin 38 (and through the soft tissue protector and drillsleeve), a pilot bore 42 may be drilled with cannulated drill bit 40, asis diagrammatically shown in FIG. 7C. The pilot bore 42 may extendthrough the ilium, through the SI-Joint, and into the sacrum. The drillbit 40 and drill sleeve (not shown) are then removed.

A shaped broach 44 may be tapped into the pilot bore 42 over the guidepin 38 (and through the soft tissue protector, not shown) to create abroached bore 48 with the desired profile for the implant structure 20,which, in the illustrated embodiment, is triangular. This generallycorresponds to the sequence shown diagrammatically in FIG. 7D. Thetriangular profile of the broached bore 48 is also shown in FIG. 8.

FIGS. 7E and 7F illustrate an embodiment of the assembly of a softtissue protector or dilator or delivery sleeve 200 with a drill sleeve202, a guide pin sleeve 204 and a handle 206. In some embodiments, thedrill sleeve 202 and guide pin sleeve 204 can be inserted within thesoft tissue protector 200 to form a soft tissue protector assembly 210that can slide over the guide pin 208 until bony contact is achieved.The soft tissue protector 200 can be any one of the soft tissueprotectors or dilators or delivery sleeves disclosed herein. In someembodiments, an expandable dilator or delivery sleeve 200 can be used inplace of a conventional soft tissue dilator. In the case of theexpandable dilator, in some embodiments, the expandable dilator can beslid over the guide pin and then expanded before the drill sleeve 202and/or guide pin sleeve 204 are inserted within the expandable dilator.In other embodiments, insertion of the drill sleeve 202 and/or guide pinsleeve 204 within the expandable dilator can be used to expand theexpandable dilator.

In some embodiments, a dilator can be used to open a channel though thetissue prior to sliding the soft tissue protector assembly 210 over theguide pin. The dilator(s) can be placed over the guide pin, using forexample a plurality of sequentially larger dilators or using anexpandable dilator. After the channel has been formed through thetissue, the dilator(s) can be removed and the soft tissue protectorassembly can be slid over the guide pin. In some embodiments, theexpandable dilator can serve as a soft tissue protector after beingexpanded. For example, after expansion the drill sleeve and guide pinsleeve can be inserted into the expandable dilator.

As shown in FIGS. 8 and 9, a triangular implant structure 20 can be nowtapped through the soft tissue protector over the guide pin 38 throughthe ilium, across the SI-Joint, and into the sacrum, until the proximalend of the implant structure 20 is flush against the lateral wall of theilium (see also FIGS. 5 and 10). The guide pin 38 and soft tissueprotector are withdrawn, leaving the implant structure 20 residing inthe broached passageway, flush with the lateral wall of the ilium (seeFIGS. 5 and 10). In the illustrated embodiment, two additional implantstructures 20 are implanted in this manner, as FIG. 9 best shows. Inother embodiments, the proximal ends of the implant structures 20 areleft proud of the lateral wall of the ilium, such that they extend 1, 2,3 or 4 mm outside of the ilium. This ensures that the implants 20 engagethe hard cortical portion of the ilium rather than just the softercancellous portion, through which they might migrate if there was nostructural support from hard cortical bone. The hard cortical bone canalso bear the loads or forces typically exerted on the bone by theimplant 20.

The implant structures 20 are sized according to the local anatomy. Forthe SI-Joint, representative implant structures 20 can range in size,depending upon the local anatomy, from about 35 mm to about 60 mm inlength, and about a 7 mm inscribed diameter (i.e. a triangle having aheight of about 10.5 mm and a base of about 12 mm). The morphology ofthe local structures can be generally understood by medicalprofessionals using textbooks of human skeletal anatomy along with theirknowledge of the site and its disease or injury. The physician is alsoable to ascertain the dimensions of the implant structure 20 based uponprior analysis of the morphology of the targeted bone using, forexample, plain film x-ray, fluoroscopic x-ray, or MRI or CT scanning.

Using a lateral approach, one or more implant structures 20 can beindividually inserted in a minimally invasive fashion across theSI-Joint, as has been described. Conventional tissue access tools,obturators, cannulas, and/or drills can be used for this purpose.Alternatively, the novel tissue access tools described above and in U.S.Provisional Patent Application No. 61/609,043, titled “TISSUE DILATORAND PROTECTOR” and filed Mar. 9, 2012, and in U.S. Published ApplicationNo. 2017/0007409, titled “SYSTEMS, DEVICES, AND METHODS FOR JOINTFUSION” and filed Jul. 12, 2016, can also be used. No joint preparation,removal of cartilage, or scraping are required before formation of theinsertion path or insertion of the implant structures 20, so a minimallyinvasive insertion path sized approximately at or about the maximumouter diameter of the implant structures 20 can be formed.

The implant structures 20 can obviate the need for autologous bone graftmaterial, additional pedicle screws and/or rods, hollow modularanchorage screws, cannulated compression screws, threaded cages withinthe joint, or fracture fixation screws. Still, in the physician'sdiscretion, bone graft material and other fixation instrumentation canbe used in combination with the implant structures 20.

In a representative procedure, one to six, or perhaps up to eight,implant structures 20 can be used, depending on the size of the patientand the size of the implant structures 20. After installation, thepatient would be advised to prevent or reduce loading of the SI-Jointwhile fusion occurs. This could be about a six to twelve week period ormore, depending on the health of the patient and his or her adherence topost-op protocol.

The implant structures 20 make possible surgical techniques that areless invasive than traditional open surgery with no extensive softtissue stripping. The lateral approach to the SI-Joint provides astraightforward surgical approach that complements the minimallyinvasive surgical techniques. The profile and design of the implantstructures 20 minimize or reduce rotation and micromotion. Rigid implantstructures 20 made from titanium provide immediate post-op SI-Jointstability. A bony in-growth region 24 comprising a porous plasma spraycoating with irregular surface supports stable bone fixation/fusion. Theimplant structures 20 and surgical approaches make possible theplacement of larger fusion surface areas designed to maximizepost-surgical weight bearing capacity and provide a biomechanicallyrigorous implant designed specifically to stabilize the heavily loadedSI-Joint. In some embodiments, a fenestrated matrix implant may be used,providing cavities in which to pack bone growth material, and orproviding additional surface area for bone on-growth, in-growth and orthrough-growth.

To improve the stability and weight bearing capacity of the implant, theimplant can be inserted across three or more cortical walls. Forexample, after insertion the implant can traverse two cortical walls ofthe ilium and at least one cortical wall of the sacrum. The corticalbone is much denser and stronger than cancellous bone and can betterwithstand the large stresses found in the SI-Joint. By crossing three ormore cortical walls, the implant can spread the load across more loadbearing structures, thereby reducing the amount of load borne by eachstructure. In addition, movement of the implant within the bone afterimplantation is reduced by providing structural support in threelocations around the implant versus two locations.

Further details of bone joint implants and methods of use can be foundin U.S. Pat. No. 8,308,779 entitled “SYSTEMS AND METHODS FOR THEFIXATION OR FUSION OF BONE” filed Feb. 25, 2008, U.S. Pat. No. 7,922,765entitled “SYSTEMS AND METHODS FOR THE FIXATION OR FUSION OF BONE” filedMar. 24, 2005, U.S. Pat. No. 8,986,348 entitled “SYSTEMS AND METHODS FORTHE FUSION OF THE SACRAL-ILIAC JOINT” filed Oct. 5, 2010, and U.S. Pat.No. 8,414,648 entitled “APPARATUS, SYSTEMS, AND METHODS FOR ACHIEVINGTRANS-ILIAC LUMBAR FUSION” filed Dec. 6, 2010

In the previously described methods, the implant(s) 10 or 20 (FIGS. 3and 4) may be placed in the implant bore(s) 48 (FIG. 8) with noadditional preparation of the SI-Joint. In other embodiments, accordingto aspects of the present disclosure, all or portions of thearticulating surfaces of the SI-Joint may be decorticated, typicallyprior to placing the implant(s), as will now be described.

Referring to FIG. 11A, an exemplary embodiment of a decorticating systemand method is shown. Cutting instrument 300 is provided with a main body310 which has triangular portions 312 and 314 at its distal and proximalends, respectively. Triangular portions 312 and 314 are configured to beslidably received within the triangular bore of the soft tissueprotector 200 shown in FIG. 7E and prevent body 310 from rotating withinsoft tissue protector 200. A stop 316 may be located proximal to theproximal triangular portion 314. Stop 316 is configured to abut againstthe proximal end of soft tissue protector 200 to limit the distal travelof body 310 into soft tissue protector 200.

Body 310 is provided with a cylindrical bore therethrough along itslongitudinal axis for slidably and rotatably receiving drive shaft 318.Drive shaft 318 may be provided with a longitudinal bore 320 sized toslide over guide pin 208 (shown in FIG. 7E.) Cutter 322 may be locatedon or near the distal end of drive shaft 318, and affixed thereto bythreading, welding, press fitting, adhesive, or other suitableattachment means such that cutter 322 rotates in unison with drive shaft318. A handle 324 may be provided at the proximal end of drive shaft 318to allow an operator to manually rotate cutter 322. In some embodiments,a motor or other drive mechanism (not shown) may be coupled to driveshaft 318 to allow automatic rotation.

In the embodiment illustrated in FIG. 11A, cutter 322 is provided withthree radially extending cutting tips, each extending the same distancefrom bore 320 and the axis of rotation. Cutter 322 is shaped and sizedto fit through the triangular bore of soft tissue protector 200 (shownin FIG. 7E) and through the triangular bore 48 broached in the bone(shown in FIG. 7D.) During operation, handle 324 (shown in FIG. 11A) maybe used to distally advance cutter 322 through the distal end of thesoft tissue protector 200, through broached bore 48 in Bone Segment 1(such as the ilium, depicted in FIG. 7D), and into the space or jointbetween the bone segments (such as generally between the articulatingsurfaces of the SI-Joint, as depicted in FIG. 7D.) Once cutter 322 is nolonger constrained by soft tissue protector 200 and broached bore 48, itmay be rotated in the space or joint between bone segments by rotatinghandle 324 (FIG. 11A.) When rotated, cutter 322 will cut into the faceof Bone Segment 1 (e.g. the ilium) and or the face of Bone Segment 2(e.g. the sacrum), creating a circular region of decortication.

Referring to FIG. 11B, at least one edge of cutter 322 may be providedwith a flat portion 326 and a curved portion 328. When cutter 322 isrotated in a first direction 330, flat portion(s) 326 engage with thebone to decorticate, and when rotated in as second direction 332, curvedportion(s) 328 engage with the bone to decorticate. In some embodiments,a generally radially extending edge of curved portion(s) 328 may beprovided with a chamfer 334 and an opposite generally radially extendingedge may be left sharp, as shown in FIG. 11B. In other embodiments (notshown), the radially extending edges on both sides of curved portion(s)328 may be left sharp. While the illustrated embodiment shows a cutter322 having three teeth or cutting extensions, other embodiments (notshown) may have one, two or more than three teeth.

Cutter 322 may be sized to completely fill the interior cross-section ofthe soft tissue protector 200 so that the reach of its cutting tips whenrotated outside of this cross-section can be maximized. The outer circle340 in FIG. 12 depicts the area reached by cutter 322. The generallytriangular area 342 within circle 340 represents the cross-sectionalarea of broached bore 48 formed in the bone, and the cross-sectionalarea of the implant. The three shaded segments 344 represent thedecorticated area of the bone face (i.e. the area of outer circle 340minus the area of triangle 342.) In some embodiments, the totaldecorticated area of the three segments 344 is about 0.64 cm² (on oneside of the joint.) In typical procedures wherein both sides of thejoint are decorticated, this area is generally the same on both jointsurfaces. In some embodiments, the cross sectional area of thetriangular working channel of the soft tissue protector 200 is alsoabout 0.64 cm² (having a base of 1.05 cm and a height of 1.212 cm.)Accordingly, the decorticated area of the joint provided by thisexemplary instrument may be about equal to the working channel it passesthrough.

In some embodiments, the axial thickness of cutter 322 is 3 mm. In someembodiments, the axial thickness of cutter 322 may be sized to bethicker than the space or joint between the bone segments so that thesurfaces of both bone segments can be decorticated at the same time. Inother embodiments, the axial thickness of cutter 322 may be sized to bethinner than the space or joint between the bone segments so that onlyone of the surfaces of the bone segments can be decorticated, or so thatone surface can first be decorticated, cutter 322 can be moved axially,and then the other surface can be decorticated. In such embodiments, thesurgeon is provided with the ability to decorticate each surfaceindependently, with different depths of decortication, different amountsof force applied, etc.

As shown in FIG. 11A, handle 324 may be provided with one or more flatportions 346 and or other clocking/indexing features showing therotational orientation of drive shaft 318 and cutter 322 relative tosoft tissue protector 200. By aligning flat portion 346 with one of theflat sides of stop 316, the surgeon can see that cutter 322 isrotationally lined up with the triangular bore of soft tissue protector200 so that cutter 322 may be withdrawn through the triangular bore. Insome embodiments, a ball detent feature, magnets, lights and or soundmay be provided to aid in determining when cutter 322 is properlyaligned for withdrawal.

According to aspects of the present disclosure, cutting instrument 300may be used to decorticate bone surface(s) as follows. As previouslydescribed, an incision through soft tissue may be made and a guide pin208 (shown in FIG. 7F) may be placed along a desired path where animplant is to be inserted. A pin sleeve 204, drill sleeve 202 and softtissue protector 200 (shown in FIG. 7E) may be placed over the guide pin208 until the distal end of soft tissue protector contacts an outer bonesurface (such as a lateral surface of an ilium.) Pin sleeve 204 may thenbe removed and replaced with a cannulated drill bit over the guide pin208 to begin forming a bore through the first bone segment (e.g. ilium)and into the second bone segment (e.g. sacrum) for receiving an implant.The drill bit and drill sleeve 202 may then be removed and a triangularshaped broach may be passed over the guide pin and through soft tissueprotector 200 to complete the bore. The broach may then be removed andcutter instrument 300 inserted over guide wire 322 such that cutter 322passes through soft tissue protector 200, through the first bone segmentand into the space or joint between the bone segments (e.g. theSI-Joint.) Imaging, such as a fluoroscope, may be used to confirm thatcutter 322 is located in the desired location within the joint. Handle324 may then be rotated in one or both directions to decorticate one orboth surfaces of the joint. During the decortication process, cutter 322may be further advanced distally and or retracted proximally. Cuttinginstrument 300 may then be removed and a triangular shaped implantpassed over guide wire 322, through soft tissue protector 200, andtapped into place across the joint. After the implant placement isconfirmed with imaging, guide wire 322 and soft tissue protector 200 maybe removed and the incision closed. In some embodiments, a guide pin isnot used, is placed later in the procedure, and or is removed earlierthan described above. In some embodiments, the drill bit is notcannulated or is not used. In some embodiments, bone graft such asautograft and/or other bone growth inducing material may be placed inthe decorticated area, before and/or after an implant is placed.

In an embodiment similar to system 300 shown in FIG. 11A, a triangularcomponent (not shown) may be provided distal to the cutting element forguiding the cutting element toward the implant bore formed on theopposite side of the bone joint, and or for stabilizing the cuttingelement during operation.

Referring to FIG. 13A, another exemplary cutter 322B is shown which maybe used instead of cutter 322 on instrument 300 as previously described.Cutter 322B may be provided with curved and or straight, flexible metalbristles, ribbons, or blades 326B. As cutter 322B is rotated thebristles are able to deflect/flex to conform to the SI-Joint's irregularsurfaces. The flexible bristles can scrape through the joint cartilage,scratch the cortical bone, but not cut away the cortical bone. Thisleaves the cortical wall intact for better implant support. Also, as theflexible bristles scratch away the cartilage, the cartilage is capturedby the bristles like a whisk and can be removed by re-aligning thecutter with the implant bore and removing the instrument from the bone.While the illustrated embodiment shows cutter 322B having bristles allin a line, other embodiments, such as cutter 322C shown in FIG. 13B, mayhave multiple bristles that point in other directions while stillmaintaining a substantially triangular shape.

Referring to FIG. 14, another exemplary embodiment of a decorticatingsystem and method is shown. The construction and use of cuttinginstrument 400 illustrated in FIG. 14 is similar to that of cuttinginstrument 300 illustrated in FIG. 11A. As shown in FIG. 14, cuttinginstrument 400 is provided with a larger knob 410 at the proximal end ofdrive shaft 412 in order to allow the surgeon to apply more torque tocutter 414 at the distal end of drive shaft 412. Knob 410 may begenerally triangular in shape as shown, to more easily identify theangular orientation of cutter 414 when aligning it with the main body416 prior to retracting cutter 414 through the soft tissue protector, aspreviously described.

Referring to FIG. 15, an enlarged view of the distal end of drive shaft412 of cutting instrument 400 is shown with cutter 414 removed. Cutter414 (shown in FIG. 14) is provided with a central hexagonal through bore(not shown.) The distal end of drive shaft 412 is provided with a matinghexagonal rod portion 418 as shown in FIG. 15, configured to be slidablyreceived through the hexagonal bore in cutter 414. Retainer ring 420 isattached to hexagonal rod portion 418 as shown in FIG. 15 to retaincutter 414 in place on rod portion 418.

If the outer surfaces 422 of hexagonal rod portion 418 were parallel tothe central longitudinal axis 424 of drive shaft 412, cutter 414 ofcutting instrument 400 would rotate in the same way as cutter 322 ofcutting instrument 300 shown in FIG. 11A (i.e. would remain in a planeperpendicular to the axis of rotation 422.) However, in this embodimentthe outer surfaces 422 of hexagonal rod portion 418 each have a convexcurvature. In other words, hexagonal rod portion 418 is thicker at itscenter than at its proximal and distal ends. This arrangement allowscutter 414 to tip in either direction relative to axis 424. In someembodiments, cutter 414 may tip up to plus or minus 5 degrees fromperpendicular. In other embodiments (not shown), cutter 414 may tip morethan 5 degrees. Allowing cutter 414 to assume an angle that is notperpendicular to the axis of rotation 424 can be beneficial insituations where the implant bore is not formed perpendicular to thebone joint. For example, if an implant bore in made across an SI-Jointsuch that the bore crosses the joint's articulating surfaces at an 85degree angle, allowing cutter 414 to tip to a matching angle of 85degrees allows cutter 414 to more uniformly decorticate the surfaces ofthe SI-Joint around the bore implant.

In other embodiments (not shown), the hexagonal rod portion 418 and thehexagonal bore in cutter 414 may be replaced with a resilient material(such as Tygon® or other biocompatible polymer) at the distal end of thedrive shaft 412 and or central hub section of cutter 414. Such anarrangement allows the cutter to have a passively compliant angle, asdescribed above.

In other embodiments (not shown), the angle of the cutter may beactively controlled or adjusted. In some embodiments, one or moremovable pins may be provided through the main body of the cuttinginstrument. When a pin is pushed distally against the proximal side ofthe cutter, that side of the cutter is angled away from the pin and thecutter's angle relative to the axis of rotation is actively changed frombeing perpendicular to non-perpendicular. As the cutter rotates, itmaintains this set angle, even if forces from the bone joint may beurging it back towards perpendicular. In some embodiments, the distalend of the pin(s) directly contact a circular race located on theproximal side of the cutter. In other embodiments, the distal end of thepin(s) contact a ring that is set to a desired angle, and the ring inturn urges the cutter to the desired angle. If the pin(s) are connectedto the ring, they may be pushed or pulled by the surgeon to change theangle of the ring and cutter.

Referring now to FIGS. 16-18, another exemplary embodiment of adecorticating system and method is shown. FIG. 16 is a perspective viewshowing cutting instrument 500, FIG. 17 is an exploded view showingindividual components of the instrument, and FIG. 18 is an enlarged endview showing the distal end of instrument 500. Cutting instrument 500 issimilar in construction and use to the previously described instruments.Cutting instrument 500 may be provided with a cutter 510, main body 512,drive shaft 514, washer 516, adjustable stop 518, handle 520 and setscrew 522.

Triangularly shaped main body 512 may have a reduced cross-section nearits distal end to enable it to more freely pass through an implant borein bone, while the larger cross-section at the proximal end maintains asliding fit with a soft tissue protector (not shown), as previouslydescribed. Similarly, drive shaft 514 may be stepped down at its distalend as shown in FIG. 17. Drive shaft 514 is received through a bore inmain body 512 that is off-axis or laterally displaced from thelongitudinal centerline of main body 512, as best seen in FIG. 18.Non-symmetrical cutter 510 is attached to the distal end of drive shaft514 such that its profile fits within the cross-section of the softtissue protector and implant bore in at least one orientation. Thisarrangement of an off-axis drive shaft 514 and non-symmetrical cutter510 allows the cutter to reach farther away laterally from main body 512into the bone joint when the drive shaft and cutter are rotated. As canbe seen in FIG. 18, when cutter 510 is rotated in one direction, itsleading edge comprises a concave or scooped cutting edge, and whenrotated in the opposite direction the leading edge comprises a convexcutting edge.

As best seen in FIG. 17, main body 512 may be provided with externalthreads 524 configured to mate with internal threads 526 withinadjustable stop 518. Rotation of stop 518 then causes the stop to moveproximally or distally with respect to main body 512, such that thedepth that cutter 510 can travel may be adjusted.

Handle 520 may be attached to the proximal end of drive shaft 514 toallow a surgeon to rotate cutter 510. Handle 520 may also be shaped andangularly oriented similar to cutter 510 so the surgeon has a visualindication of what cutter 510 is doing inside the implant bore. In someembodiments, the proximal end of drive shaft 514 is provided with a flatportion on one side which protrudes from the proximal end of main body524, through washer 516 and into a D-shaped mating hole in handle 520 tomaintain a proper orientation between drive shaft 514 and handle 520.Similar features (not shown) may be provided between cutter 510 and thedistal end of drive shaft 514 to maintain a desired angular orientationbetween the two.

Set screw 522 may be threadably engaged with handle 520, offset from theaxis of rotation of drive shaft 514 and handle 520. A detent bore (notshown) may be provided in the proximal end of main body 512 forreceiving the distal end of set screw 522 when it is distally advancedthrough handle 520. With this arrangement, a surgeon may lock theangular orientation of cutter 510 by threading set screw 522 into itsdetent so that the cutter is aligned for passing through the soft tissueprotector and into the implant bore in the bone segment(s). Once thecutter is in position within the joint, set screw 522 may be unscreweduntil it is withdrawn from the detent bore in main body 512, therebyallowing cutter 510 to be rotated by handle 520. Before cutter 510 iswithdrawn from the joint along with main body 512 through the softtissue protector, set screw 522 can be aligned with the detent bore sothat set screw 522 may be threaded into it. In other embodiments (notshown), an indicia line or other marking may be used instead of or inaddition to handle 520 to indicate when cutter 510 is in a properorientation for removal.

In some embodiments (not shown), off-axis cutting instrument 500 may becannulated so as to slide over a guide wire that has been placed intothe joint. In such embodiments, a handle at the proximal end of driveshaft 514 may be configured so that it may be rotated withoutinterfering with the guide wire. In some embodiments (cannulated ornon-cannulated), a removable wrench may be provided such that additionaltorque may be applied to the cutter.

Referring to FIGS. 19-22, various enlarged views of cutter 510 areshown. In each view, the proximal side of cutter 510 is facing generallyup. FIG. 19 is a perspective view showing the concave side 530 andradially outward side 532 of cutter 510, FIG. 20 is a side view showingconcave side 530, FIG. 21 is perspective view showing the convex side534 and radially outward side 532, and FIG. 22 is an end view showingthe radially outward side 532.

Cutter 510 may be provided with a bore 536 for receiving the distal endof the drive shaft, as previously described. The proximal (top) anddistal (bottom) faces of cutter 510 may each be provided with an innerscraper 538 and an outer scraper 540 (also shown in FIG. 18.) In someembodiments, the main arm of cutter 510 that protrudes radially outwardfrom bore 536 is 2 mm thick, and scrapers 538 and 540 each protrudeaxially 0.5 mm from the arm, resulting in a maximum cutter arm thicknessof 3 mm.

The concave side 530 of cutter 510 may be provided with flat section anda curved section radially outward from the flat section (best seen inFIG. 18.) Concave side 530 may also be provided with a round-bottomchannel or scoop 542 extending along a portion of its length, withbeveled cutting edges located above and below channel 542. On theopposite side of the cutting arm, convex side 534 may be configured witha single, large, curved bevel, as best seen in FIGS. 21 and 22.

In some implementations, cutter tool 500 is first operated in acounterclockwise direction such that convex side 534 is the leading edgeof cutter 510, then operated in a clockwise direction such that concaveside 530 becomes the leading edge. This allows convex side 534 to firstcut through the cartilage of the joint, then allows concave side 530 toscrape the cartilage from the bone faces. Scrapers or teeth 538 and 540on both ends of cutter 510 allow for further scraping of cartilage. Insome embodiments the scooped side of the cutter when rotated directscartilage and or bone tissue into the implant bore.

Referring to FIGS. 23 and 24, the decortication area produced byoff-axis cutter system 500 is shown. The outer circle 590 in FIG. 23depicts the area reached by cutter 510 when it is located in the upperapex of main body 512. The generally triangular area 592 within circle590 represents the cross-sectional area of broached bore 48 formed inthe bone, and the cross-sectional area of the implant. The shaded area(i.e. the area inside circle 590 but outside triangular area 592)represents the decorticated area of the bone. In some embodiments, thisdecorticated area is about 1.48 cm2 (on one side of the joint.) Intypical procedures wherein both sides of the joint are decorticated,this area is generally the same on both joint surfaces. These areas aremore than double those depicted in FIG. 12 for on-axis cuttinginstrument 300. In some embodiments, the cross sectional area of thetriangular working channel of the soft tissue protector 200 is alsoabout 0.64 cm2 (having a base of 1.05 cm and a height of 1.212 cm.)Accordingly, the decorticated area of the joint provided by thisexemplary instrument may be more than double that of the working channelit passes through.

In some procedures, off-axis cutter 510 may be operated in all threeapices of the soft tissue protector to achieve an even larger area ofdecortication. In other words, main body 512 of instrument 500 may beintroduced into a soft tissue protector in one orientation as describedabove to achieve the decortication pattern depicted in FIG. 23. Thenmain body 512 is withdrawn, rotated 120 degrees, and reinserted into thesoft tissue protector to decorticate around another apex of the softtissue protector. This procedure is repeated until the area around allthree apexes is decorticated, as depicted by the 3-lobed area 594 inFIG. 24. The shaded area (i.e. the area inside perimeter 594 but outsidetriangular area 592) represents the decorticated area of the bone. Insome embodiments, this decorticated area is about 2.81 cm2 (on one sideof the joint.) In typical procedures wherein both sides of the joint aredecorticated, this area is generally the same on both joint surfaces.These areas are almost double the areas depicted in FIG. 23 when cuttinginstrument 500 is used in only one apex of the soft tissue protector. Insome embodiments, the cross sectional area of the triangular workingchannel of the soft tissue protector 200 is also about 0.64 cm2 (havinga base of 1.05 cm and a height of 1.212 cm.) Accordingly, thedecorticated area of the joint provided by this exemplary instrument maybe more than four times that of the working channel it passes through.

Referring to FIG. 25, an impactor tool 600 is shown for use withoff-axis cutter system 500. Impactor 600 may be provided with a cuppeddistal end 610 as shown, for mating with the proximal end of adjustablestop 518 (shown in FIG. 16.) A cutout portion 612 may be provided in thecupped distal end 610 so that impactor 600 may be slid on to theproximal end of cutter instrument 500 from the side before moving thecupped end distally over stop 518. Cutout portion 612 may also beconfigured to allow handle 520 (also shown in FIG. 16) to extendtherethrough. The proximal end 614 of impactor 600 may be provided withan enlarged impact surface against which a hammer may be used. With thisarrangement, the distal end of cutter instrument 500 may be tapped intoplace through the implant bore in the bone using a hammer, withoutdamaging the components located on the proximal end of main body 512.

Referring to FIG. 26, a removal tool 620 is shown for use with off-axiscutter system 500. The distal end of removal tool 620 may behalf-cylinder shaped so that it may be slid onto adjustable stop 518(shown in FIG. 16) from the side. The distal end of removal tool 620 maybe provided with a radially inwardly extending lip 630 configured toengage the distal underside of adjustable stop 518. The middle ofremoval tool 620 may comprise a rod portion 632 configured to slidablyreceive a weighted handle member (not shown.) An enlarged head portion634 may be provided at the proximal end of rod portion 632 as shown, tocaptivate the weighted handle member on the rod portion and provide itwith an impact surface. With this arrangement, removal tool 620 may beoperated as a slide hammer (also known as a slap hammer) to apply impactforce to the distal side of stop 518 so that cutter tool 500 may bepulled out from the implant bore formed in the bone.

Referring now to FIGS. 27-28, another exemplary embodiment of adecorticating system and method is shown. FIG. 27 is a perspective viewshowing cutting instrument 650, and FIG. 28 is an exploded view showingcomponents of the instrument. Cutting instrument 650 is similar inconstruction and use to the previously described instruments. Cuttinginstrument 650 may be provided with a main tube 660, a nitinol strip662, and a cap rod 664. Main tube 660 may be provided with a handle 666at its proximal end for rotating the instrument about its longitudinalaxis. At the distal end of main tube 660, a window 668 may be providedto allow a distal loop 670 of the nitinol strip 662 to be alternatelyextended and retracted through the window 668.

In this embodiment, cap rod 664 has a semi-circular cross-section, withthe flat side facing down (not seen in the figures.) When instrument 650is assembled, nitinol strip 662 extends along the flat bottom side ofcap rod 664, up along the rounded distal end of cap rod 664, and intoslot 672. Cap rod 664 and strip 662 are received within a central bore(not shown) in tube 660. An upwardly curved surface (not shown) may beprovided at the distal end of the central bore to help guide strip 662from the end of the central bore out through window 668. In someembodiments one or both edges of the distal loop 670 of strip 662 areleft square, and in other embodiments one or both edges are sharpened.

In operation, the distal end of instrument 650 may be advanced through asoft tissue protector as with previously described embodiments and intoa bone joint of a patient. Loop 670 of strip 662 remains retractedwithin tube 660 (or only slightly protruding through window 668) asinstrument 650 is being advanced. Once window 668 is positioned withinthe joint space, a proximal portion of strip 662 may be distallyadvanced, such as with a handle or other means (not shown.) In thisembodiment, the radial extension of loop 670 may be varied depending onhow far strip 662 is distally advanced, but the width of loop 670 isheld to a predetermined constant width by the proximal and distal edgesof window 668. After loop 670 has been extended to a desired length,handle 666 is turned in one or both directions to decorticate one orboth sides of the joint. The proximal portion of strip 662 is thenretracted proximally to retract loop 670 into window 668 so thatinstrument 650 may be withdrawn.

In some embodiments, instrument 650 may be used in conjunction with aguidewire (not shown.) With the guidewire in place across a bone joint,main tube 660 may be advanced along the guidewire without nitinol strip662 and cap rod 664 in place inside the tube. The guidewire may then beremoved from the joint and nitinol strip 662 and cap rod 664 insertedthrough main tube 660. Alternatively, instrument 650 may be configuredto allow nitinol strip 662 and cap rod 664 to be inserted into main tube660 before it is placed over the guidewire and into the bone joint.

Referring now to FIG. 29, another exemplary embodiment of adecorticating system and method is shown. Cutting instrument 680 is verysimilar in construction and use to decorticating system 650 shown inFIGS. 27 and 28. However, instead of having a nitinol strip 662 with aU-shaped distal end 670 (as best seen in FIG. 28), cutting instrument680 is provided with a nitinol strip 690 having a lollipop-shaped distalend 692. One or both edges of distal end 692 may be sharpened as shown.A series of holes and or protrusions may also be provided such as thoseshown to allow distal end 692 to have a rasp-like action. With thisarrangement, an annular-shaped decorticated area is formed when distalend 692 is rotated about the longitudinal axis of instrument 680.Leaving non-decorticated bone directly adjacent to the implant mayincrease the stability of the implant. By making a full revolution withdistal end 692, a donut-shaped cut is made around the implant bore.Alternatively, a partial revolution may be made, leaving an arc ofdecorticated area, with a central non-decorticated region connected toan outward non-decorticated region. In some embodiments, this arcextends 120 degrees. In other embodiments, distal end 692 may beextended, rotated a partial revolution, retracted and further rotated(so that it is no longer decorticating bone), extended again, andfurther rotated, to create multiple arcs of decorticated area. Usingsuch a method, the central non-decorticated region may be connected tothe outward non-decorticated region by two or more spokes ofnon-decorticated bone.

Referring now to FIGS. 30-31, another exemplary embodiment of adecorticating system and method is shown. FIG. 30 is a perspective viewshowing cutting instrument 700 in an expanded state, and FIG. 31 is anenlarged view showing the distal end of the instrument in the expandedstate. Cutting instrument 700 is similar in construction and use to thepreviously described instruments. Cutting instrument 700 may be providedwith a main body 710, inner body 712, connecting arm 714 and cutting arm716. Inner body 712 may be partially received in a bore in main body710, and may slidably move distally and proximally with respect to mainbody 710, as depicted by Arrow A in FIG. 30.

As best seen in FIG. 31, the proximal end of connecting arm 714 may bepivotally connected to the distal end of inner body 712 by a first pin(not shown) located on axis 718. The distal end of connecting arm 714may be pivotally connected to a mid-portion of cutting arm 716 by asecond pin (not shown) located on axis 720. The distal end of cuttingarm 716 may be pivotally connected to a distal portion of main body 710by a third pin (not shown) located on axis 722. With this arrangement,the first pin on axis 718 and the third in on axis 722 are bothconstrained from translating in a radial direction, whereas the secondpin on axis 720 is not. As such, when inner body 712 is moved distally,the distal end of connecting arm 714 moves radially outward to theposition shown as the proximal end rotates about axis 718. This drivesthe proximal portion of cutting arm 716 radially outward to thepositions shown as the distal end pivots about axis 722. When inner body712 is moved proximally, connecting arm 714 and cutting arm 716 moveradially inward to a retracted position (not shown.) When connecting arm714 and cutting arm 716 are in the retracted position, they fit intocomplementary shaped recesses in the distal end of main body 710 suchthat the assembly generally forms a cylindrical shape. In someembodiments, this cylindrical shape does not exceed 7 mm, allowing thedistal end of instrument 700 to fit within a 7 mm bore in the bone.

In operation, when cutting arm 716 is extended as just described,cutting instrument 700 may be rotated to allow cutting arm 716 todecorticate the bone joint. In some embodiments, connecting arm 714 mayserve as a cutter as well, or instead of arm 716.

Referring now to FIGS. 32-33, another exemplary embodiment of adecorticating system and method is shown. FIG. 32 is a perspective viewand FIG. 33 is a side view, both showing longitudinal cross-sections ofcutting instrument 730 in a retracted state. Cutting instrument 730 issimilar in construction and use to the previously described instruments.Cutting instrument 730 may be provided with a main tube 740, a wedge742, an actuation knob 744, a cutting piece 746, and a compressionspring 748.

In this embodiment, wedge 742 is an elongated rod with a ramp formed onits distal end and external threads formed on its proximal end. Wedge742 may be received within a central bore of main tube 740.Inter-engaging features (not shown) may be provided on main tube 740 andwedge 742 to allow longitudinal movement but prevent rotational movementwith respect to one another. The proximal end of main tube 740 may beprovided with an outwardly protruding ring 750 or similar feature tocaptivate actuation knob 744 on main tube 740, prevent it from movinglongitudinally but allow it to rotate with respect to main tube 740 andwedge 742. The proximal end of wedge 742 may be provided with externalthreads that mate with the internal threads of actuation knob 744, suchthat when knob 744 is turned in one direction wedge 742 is drivendistally, and when turned in the opposite direction knob 744 driveswedge 742 proximally.

The distal end of main tube 740 may be provided with a window 752 whichpermits cutting piece 746 to move radially outward from a retractedposition (as shown) to an extended position (not shown), in which aportion of cutting piece 746 extends beyond the outer diameter of maintube 740. Cutting piece 746 may be provided with a portion that engageswith the ramp formed on the distal end of wedge 742. With thisarrangement, when actuation knob 744 drives wedge 742 distally, wedge742 in turn drives a portion of cutting piece 746 radially outwardthrough window 752 against the force of compression spring 748. Withcutting piece 746 extended, instrument 730 may be rotated to decorticatea bone joint. When wedge 742 is driven proximally by knob 744, spring748 returns cutting piece 746 to the retracted position.

Referring now to FIGS. 34-35, another exemplary embodiment of adecorticating system and method is shown. FIG. 34 is a perspective viewshowing cutting instrument 760, and FIG. 35 is an exploded view showingcomponents of the instrument, with both figures showing the outercomponents in a transparent fashion so that inner features may be seen.Cutting instrument 760 is similar in construction and use to thepreviously described instruments. Cutting instrument 760 may be providedwith a main body 770, a drive rod 772 and a cutter arm 774.

Drive rod 772 may be slidably received within a central bore in mainbody 770. Cutter arm 774 may be pivotably attached to the distal end ofdrive rod 772 with a pin (not shown.) The distal end of main body 770may be provided with a window 776 radially connecting the central boreof main body 770 with the exterior. An outwardly extending ramp 778 maybe provided at the distal end of the central bore such that when driverod 772 and cutter arm 774 are urged in a distal direction, a distal,curved portion of cutter arm 774 engages with ramp 778 and cutter arm774 is pivoted radially outward through window 776. Once cutter arm 774is radially extended, instrument 760 may be rotated to decorticate thebone joint. Pulling proximally on drive rod 772 causes the proximal sideof cutter arm 774 to contact the proximal side of window 776, causingcutter arm 774 to retract within main body 770.

A longitudinally extending spline 780 or similar feature may be providedon the exterior of drive rod 772 for mating with a groove 782 located onthe interior of main body 770. This arrangement allows drive rod 772 toslide longitudinally but not rotate inside main body 770, to preservethe correct orientation of cutter arm 774 with respect to window 776. Insome embodiments, the main body may be provided with telescopingfeatures to allow its length to be adjusted.

Referring now to FIGS. 36-37, another exemplary embodiment of adecorticating system and method is shown. FIG. 36 is a perspective viewshowing cutting instrument 800, and FIG. 37 is an exploded view showingcomponents of the instrument, with both figures showing the outercomponents in a transparent fashion so that inner features may be seen.Cutting instrument 800 is similar in construction and use to thepreviously described instruments. Cutting instrument 800 may be providedwith a main assembly 810 and a rasp assembly 812 that fits over thedistal portion of main assembly 810.

In this embodiment, the distal tip of main assembly 810 is provided witha broach 814. Broach 814 may have a triangular cross-section as shown,for forming a channel across a bone joint for receiving a triangularimplant. The distal end of rasp assembly 812 may be provided with aflexible, tubular-shaped wire rasp 816. Both FIGS. 36 and 37 show rasp816 in a radially retracted state. Rasp 816 may be connected to anactuation handle 818 by a slotted tube 820. When rasp assembly 812 isassembled with main assembly 810, longitudinal rails 822 projectradially inward from the inside diameter of a main tubular portion ofmain assembly 810 and through the elongated slots of slotted tube 820.This arrangement allows rasp assembly 812 to move axially but not rotatewith respect to main assembly 810.

In operation, the distal end of instrument 800 is tapped across a bonejoint as broach 814 forms or further forms an implant bore in the bonesegments on either side of the bone joint. Rasp 816 is positioned suchthat its center generally resides in the joint space. Actuation handle818 is then pushed distally, causing tubular rasp 816 to be pushedagainst the proximal side of broach 814, foreshorten and expand into thejoint space. Once expanded (not shown), the central portion of rasp 816will generally take on a disc shape having a larger diameter, and athickness generally equal to the width of the joint space. The proximaland distal portions of rasp 816 may maintain their original cylindricalshape. Instrument 800 may then be rotated, causing rasp 816 todecorticate bone face(s) of the joint. By urging instrument 800 in theproximal and or distal direction(s), more force may be applied to onebone face as rasp 816 is rotated. In some embodiments, because of thebraided wire structure of rasp 816, it is able to provide a moreresilient force against the bone surfaces of the joint than a fixedcutting blade, resulting in a more uniform decortication of the joint.After the joint has been decorticated, actuation handle 818 may bepulled proximally to retract rasp 816 toward its original shape so thatit may be removed from the bone joint.

Referring to FIG. 38, a further aspect of the disclosure will bedescribed. FIG. 38 shows the right lateral side of a sacrum 838, withthe ilium removed for clarity. In some embodiments, one or more extrachannels may be formed in the bone to aid in decorticating the bonejoint. These channels may have a circular, triangular, or other shape.For example, an extra triangular channel (not shown) may be formedthrough the right ilium and into and/or across an SI-Joint. The extrachannel may be formed parallel to one or more implant bores 850. Thisextra channel is not used to receive an implant 852 as are the otherthree channels 850 shown in FIG. 38. Instead, it is formed to receive adecortication instrument (not shown), such as those described herein.The decortication instrument may be used to decorticate or aid indecorticating the area(s) around the implant bore(s) 850, and or it maybe used to decorticate an area 840 around the extra bore. In the exampleshown in FIG. 38, three implant bores 850 are created across theSI-Joint, each for receiving an implant 852. Before the implants 852 areplaced in bores 850, bores 850 and the extra bore are used todecorticate the bone joint adjacent to each bore, such as previouslydescribed. Bone graft chips or other filler material may be placed intothe extra channel after it is used for decortication. In someembodiments, the typical spacing between implants is about 15 mm. Insome embodiments, some or all of the boomerang shaped articular region854 of the SI-Joint is decorticated. In some embodiments, decorticationis performed posterior or dorsal to the articular region.

Referring to FIG. 39, features may be provided on or added to thedecortication instruments described herein to aid in navigation of theinstrument, particularly with regard to a reference frame associatedwith a patient on an imaging system. For example, navigation array 870may be permanently or removably mounted near the proximal end of driveshaft 318 of decortication system 300. In the exemplary embodimentshown, four emitters or reflectors 880 are located at predetermined andunique distances from one another on array 870 to generate a signalrepresenting the trajectory, depth and or orientation of cutter 322relative to a portion of a patient's anatomy. In some embodiments,navigation array 870 may include tracking devices capable of beingtracked by a corresponding sensor array, such as, for example, atracking device that actively generates light signals, acoustic signals,magnetic signals, electromagnetic signals and or radiologic signals.Array 870 may passively reflect such signals that are then received by acorresponding sensor array. For example, four reflectors 880 may beprovided in the form of reflective spheres of a predetermined diameterwhose positions are tracked by navigation system cameras. Furtherdetails on how such navigation systems may be implemented can be foundin the following references: U.S. Pat. No. RE45,484 to Foley et al.,U.S. Pat. No. 8,467,851 to Mire et al., U.S. Pat. No. 6,556,857 to Esteset al., and U.S. Pat. No. 9,451,999 to Simpson et al. Medtroniccurrently provides a navigation array under the product name SureTrak®for use with their StealthStation® surgical imaging and navigationsystem.

Referring to FIGS. 40-42, another exemplary embodiment of adecorticating system and method is shown. FIG. 40 shows cuttinginstrument 900 in a closed state, FIG. 41 shows the instrument in anopen state, and FIG. 42 is an exploded view showing components of theinstrument. System 900 includes three thin blades 910 to help align thecutter 912 with the instrument body 914 as it's being advanced andremoved from the pelvis and soft tissue protector. Instrument 900further includes handle 916, drive shaft 918, adjustable stop 920,ball-nose spring plunger 922, and washer stop 924 (shown only in FIG.42.) The proximal ends of blades 910 may be rigidly attached to recesses925 located at the distal end of body 914.

As shown in FIG. 42, drive shaft 918 may be provided with two detents926 and 928. Each detent is configured to alternately engage withball-nose spring plunger 922 when it is threaded into the proximal endof body 914. Handle 916 may be used to pull drive shaft 918 proximallyso that plunger 922 engages with distal detent 926 and cutter 912 isretracted into blades 910 as shown in FIG. 40, or to push drive shaft918 distally so that plunger 922 engages with proximal detent 928 andcutter 912 is extended from blades 910 as shown in FIG. 41. Cutter 912may be placed in the retracted state as shown in FIG. 40 when instrument900 is being moved into and out of the patient, and may be placed in theextended state as shown in FIG. 41 when being used to decorticate a bonejoint.

Referring to FIG. 43, another exemplary embodiment of a decorticatingsystem and method is shown. FIG. 43 shows a distal tip end view ofinstrument 940, both in a closed position (upper inset figure) and anopen position (lower inset figure.) Instrument 940 has a tubular body950, a drive shaft 952 located within the body 950, and a decorticatingwire 954 having ends attached to both the drive shaft 952 and tubularbody 950. When drive shaft 952 is turned in one direction relative tothe body (clockwise in FIG. 43), wire 954 is wound around drive shaft952 and retracted within body 950, as shown in the upper inset. Whendrive shaft 952 is turned in the opposite direction, wire 954 at leastpartially unwinds from drive shaft 952 and extends radially outwardthrough an opening in body 950, as shown in the lower inset.

In operation, the distal tip of instrument 940 may be advanced into thebone joint of a patient when the instrument is in the closed position.The instrument may then be moved into its open position as describedabove to extend the cutting wire 954, and the entire instrument may thenbe rotated about its longitudinal axis to decorticate the bone jointwith wire 954. The wire 954 may then be retracted again to remove theinstrument from the patient.

In some embodiments, wire 954 of instrument 940 may be coated with anabrasive. Wire 954 may include attached cutters, barbs, sharp edges, asquare cross-section, twisted filaments, lines/slots cut therein, etc.(not shown.)

Referring to FIG. 44, another exemplary embodiment of a decorticatingsystem and method is shown. FIG. 44 is an exploded view showingcomponents of system 970. System 970 includes an outer tube 980, aninner drive shaft 982, a handle 984 attached to the proximal end ofdrive shaft 982, a right-hand threaded tube 986, a left-hand threadedtube 988, and a cutting band 990 spanning between tubes 986 and 988 asshown. Inner drive shaft 982 is received within a central bore of outertube 980 and retained there by a retainer clip 992. The distal end ofdrive shaft 982 is provided with a right-hand threaded section 994 and aleft-hand threaded section 996 for receiving right-hand threaded tube986 and left-hand threaded tube 988, respectively. Slots 998 areprovided in outer tube 980 to receive radially extending tabs onthreaded tubes 986 and 988, to prevent tubes 986 and 988 from rotatingbut allowing them to translate axially with respect to outer tube 980and inner drive shaft 982. Alternatively, pins 999 may pass throughslots 998 and be connected to tubes 986 and 988, as depicted in FIG. 44.

In operation, inner drive shaft 982 may be rotated with respect to outertube 980 by using handle 984. With the previously described arrangementof right and left-hand threaded tubes on drive shaft 982, turning driveshaft 982 in one direction causes threaded tubes 986 and 988 to movecloser together, and turning drive shaft 982 in the opposite directioncauses threaded tubes 986 and 988 to move farther apart. When threadedtubes 986 and 988 move closer together, a middle portion of band 990extends radially outward from inner drive shaft 982 and through a window1000 in outer tube 980. The farther handle 984 is rotated, the fartherband 990 extends outwardly through window. However, in some embodiments,regardless of the distance that band 990 extends through window 1000,the distance between its two extending portions (in the axial directionof the instrument) remains essentially the same, controlled by the axialwidth of window 1000.

With band 990 retracted within outer tube 980, the distal end ofinstrument 970 may be inserted into a bone joint in a manner similar topreviously described embodiments. Band 990 may then be extended throughwindow 1000 in outer tube 980 and the instrument rotated to decorticatethe bone joint. In some embodiments, the center tip of band 990 isextended about 10 to 15 mm outside of window 1000. In some embodiments,band 990 is extended to a first radius to decorticate a first innerregion of the joint, and then further extended to at least a secondradius to decorticate a second outer region of the joint. After thejoint has been sufficiently decorticated, band 990 may be retracted intoouter tube 980 by turning handle 984 in an opposite direction andinstrument 970 may be withdrawn from the patient.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present disclosure.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and variations such as“comprises” and “comprising” means various components can be co-jointlyemployed in the methods and articles (e.g., compositions and apparatusesincluding device and methods). For example, the term “comprising” willbe understood to imply the inclusion of any stated elements or steps butnot the exclusion of any other elements or steps.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical valuesgiven herein should also be understood to include about or approximatelythat value, unless the context indicates otherwise. For example, if thevalue “10” is disclosed, then “about 10” is also disclosed. Anynumerical range recited herein is intended to include all sub-rangessubsumed therein. It is also understood that when a value is disclosedthat “less than or equal to” the value, “greater than or equal to thevalue” and possible ranges between values are also disclosed, asappropriately understood by the skilled artisan. For example, if thevalue “X” is disclosed the “less than or equal to X” as well as “greaterthan or equal to X” (e.g., where X is a numerical value) is alsodisclosed. It is also understood that the throughout the application,data is provided in a number of different formats, and that this data,represents endpoints and starting points, and ranges for any combinationof the data points. For example, if a particular data point “10” and aparticular data point “15” are disclosed, it is understood that greaterthan, greater than or equal to, less than, less than or equal to, andequal to 10 and 15 are considered disclosed as well as between 10 and15. It is also understood that each unit between two particular unitsare also disclosed. For example, if 10 and 15 are disclosed, then 11,12, 13, and 14 are also disclosed.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the disclosure as described by the claims. Forexample, the order in which various described method steps are performedmay often be changed in alternative embodiments, and in otheralternative embodiments one or more method steps may be skippedaltogether. Optional features of various device and system embodimentsmay be included in some embodiments and not in others. Therefore, theforegoing description is provided primarily for exemplary purposes andshould not be interpreted to limit the scope of the disclosure as it isset forth in the claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

What is claimed is:
 1. A system for decorticating at least one bonesurface, the system comprising: an elongated soft tissue protectorhaving a bore extending therethrough, the bore having a non-circularlateral cross-section, a maximum lateral extent and a minimum lateralextent; an elongated drive shaft having a proximal and a distal end; anda cutter located on or near the distal end of the drive shaft, thecutter having a non-circular lateral cross-section, a maximum lateralextent and a minimum lateral extent, the maximum lateral extent of thecutter being greater than the minimum lateral extent of the bore but nogreater than the maximum lateral extent of the bore, wherein the bore ofthe soft tissue protector is configured to slidably receive the cuttertherethrough, wherein the minimum lateral extent of the bore preventsthe maximum lateral extent of the cutter from rotating when inside thebore but allows the drive shaft to rotate when the cutter is extendedfrom a distal end of the bore.
 2. The system of claim 1, wherein thebore of the soft tissue protector has a rectilinear lateralcross-sectional profile.
 3. The system of claim 2, wherein therectilinear lateral cross-sectional profile is generally triangular inshape.
 4. The system of claim 1, wherein the system further comprises abody that is provided with a cylindrical bore therethrough, wherein thecylindrical bore is configured to slidably and rotatably receive thedrive shaft, and wherein the body is configured to be slidably receivedwithin the bore of soft tissue protector.
 5. The system of claim 1,wherein the drive shaft and cutter are provided with a longitudinal boresized to slide over a guide pin.
 6. The system of claim 1, wherein theproximal end of the drive shaft is provided with a handle configured toallow the drive shaft to be manually rotated and moved longitudinallyrelative to the soft tissue protector.
 7. The system of claim 1, whereinthe proximal end of the drive shaft is provided with an indexing featureconfigured to show a rotational orientation of the drive shaft and thecutter relative to the soft tissue protector so that the cutter can bealigned with and retracted into the soft tissue protector.
 8. The systemof claim 1, further comprising a navigation array mounted near theproximal end of the drive shaft, the array including a plurality ofemitters or reflectors located at predetermined and unique distancesfrom one another to generate a signal to aid in navigation of the cutterwith regard to a reference frame associated with a patient on an imagingsystem.
 9. A method of decorticating at least one bone surface, themethod comprising: forming an implant bore across a first bone into aspace between the first bone and an adjacent second bone, the implantbore having a non-circular lateral cross-section, a maximum lateralextent and a minimum lateral extent; inserting a cutter of adecorticating device through the non-circular implant bore and into thespace between the first and second bones, the cutter having anon-circular lateral cross-section, a maximum lateral extent and aminimum lateral extent, the maximum lateral extent of the cutter beinggreater than the minimum lateral extent of the implant bore but nogreater than the maximum lateral extent of the implant bore; androtating the cutter of the decorticating device such that the maximumlateral extent of the cutter extends laterally beyond the implant boreand decorticates a surface of at least one of the first and secondbones.
 10. The method of claim 9, wherein the first bone is an ilium andthe second bone is a sacrum.
 11. The method of claim 9, wherein themethod further comprises withdrawing the cutter from the implant boreand placing an implant into the implant bore.
 12. The method of claim 9,wherein the implant bore has a rectilinear lateral cross-sectionalprofile.
 13. The method of claim 12, wherein the rectilinear lateralcross-sectional profile is generally triangular in shape.
 14. The methodof claim 9, wherein the method further comprises inserting a guide pinacross the first bone and into the second bone, and sliding the cutterof the decortication device over the guide pin.
 15. The method of claim9, wherein the decorticating device further comprises a handle and adrive shaft interconnecting the handle to the cutter, and wherein themethod further comprises manually manipulating the handle to rotate thecutter and to move the cutter longitudinally relative to the implantbore.
 16. The method of claim 15, wherein the handle or a proximal endof the drive shaft is provided with an indexing feature configured toshow a rotational orientation of the drive shaft and the cutter relativeto the implant bore, wherein the method further comprises manipulatingthe handle to align the cutter with and retract the cutter through thenon-circular implant bore.
 17. A system for decorticating at least onebone surface, the system comprising: an elongated drive shaft; anelongated body having a central longitudinal axis, the body having abore extending therethrough, wherein the bore is parallel to andlaterally offset from the central longitudinal axis, wherein the bore isconfigured to slidably and rotatably receive the drive shafttherethrough; and a non-symmetrical offset cutter located on or near adistal end of the drive shaft, the cutter having a profile that fitswithin a lateral cross-section of the elongated body in at least oneorientation and extends laterally outside of the cross-section when thedrive shaft and cutter are rotated.
 18. The system of claim 17, whereinthe lateral cross-section of the elongated body has a rectilinearprofile.
 19. The system of claim 18, wherein the rectilinear profile isgenerally triangular in shape.
 20. The system of claim 17, furthercomprising a navigation array mounted near a proximal end of the driveshaft, the array including a plurality of emitters or reflectors locatedat predetermined and unique distances from one another to generate asignal to aid in navigation of the cutter with regard to a referenceframe associated with a patient on an imaging system.